Systems and methods for monitoring pill taking

ABSTRACT

Systems and methods are disclosed for dispensing one or more pills from a pill box by applying power when the one or more pills are poured from the pill box; identifying an opened compartment and an opening time; and recording the opened compartment and the opening time.

BACKGROUND

This invention relates to pill dispensers.

The usage of pills to regain and maintain health has increased with theadvancement of medical science. It is not unusual for a person to takemore than one type of pill, each type in a different amount, at regulartimes each day. The task of correctly taking several different types ofpills pose a challenge to many individuals, especially the elderly, thementally infirm, and the obtunded who are more susceptible to memoryproblems. The improper taking of pills may be detrimental to health, andmany emergency hospital admissions are attributable to improperobservance of pill prescriptions.

The need for a device that will automatically dispense the properpill(s) in the proper amount(s) at the proper time(s) each day and alertthe user of the device to take the dispensed pill(s) is evident by thenumerous devices described in the prior art. However, there are problemswith the devices described in the prior art. For example, U.S. Pat. No.4,573,606 to Lewis et al. (1986), U.S. Pat. No. 4,674,651 to Scidmore etal. (1987), U.S. Pat. No. 4,838,453 to Luckstead (1989), and U.S. Pat.No. 5,044,516 to Hoar (1991) describe automatic pill dispensers whichhave pill-storage wheels that are rotated constantly by electric clockmotors. The constantly rotating pill-storage wheels of these devicessuccessively move each pill-storage compartment of the wheel into atemporary alignment with a pill discharge outlet at a cyclical and fixedtime interval. When a pill-storage compartment is in alignment with thepill discharge outlet, any pill stored in the compartment will fall bygravity through the outlet into a pill receptacle. The length of thefixed time interval of these devices cannot be changed without changingthe gear drive ratio of the gear system driving the pill-storage wheel.Discharging pills at fixed time intervals makes these devicesinefficient and difficult to use. For example, if one of these devicesconstantly rotates three pill-storage compartments past its pilldischarge outlet in a 24-hour period, but only one pill is needed eachday, then only one pill-storage compartment is used and two are keptempty each 24-hour day. In this case, two out of three pill-storagecompartments have no use. In addition, during the process of loadingpills into the pill storage wheel, specific compartments must be keptempty; this makes the loading procedure more complicated and susceptibleto error.

Another problem with all of these devices is the possibility of anoverdose of dispensed pills. This may result when a device dispensespills into the pill receptacle, but the person taking the dispensedpills for some reason did not respond to the alert signal or just turnedoff the alert signal without taking the pills. If the dispensed pillsare not removed from the pill receptacle and more pills are dischargedinto the receptacle, overdosing with harmful consequences may occur ifthe pill taker consumes all of the pills accumulated in the pillreceptacle all at once.

Benaroya in U.S. Pat. No. 4,572,403 (1983), and Shaw in U.S. Pat. No.5,176,285 (1993) attempt to overcome these deficiencies. The devices ofBenaroya and Shaw include pill-storage wheels which rotate into positionfor discharging pills only when the pills are to be dispensed. A pill isnot released from Shaw's pill-storage wheel unless a motorized mechanismis actuated to remove the pill, making an accumulation of dischargedpills less likely. However, Shaw's device is complicated, difficult toload with pills and use, and uses motors and controls which are neithersimple nor economical. Pills to be dispensed by Benoroya's device arenot automatically discharged by gravity into a fixed or removable pillreceptacle. The pills stay in the pill-storage wheel until the usertilts or turns the device upside down to dump out the pills. While thisfeature makes overdosing from an accumulation of discharged pillsunlikely, the need to manipulate the device by tilting or turning itupside down and catching the pills before they fall on the floor makesits operation ackward and clumsy.

U.S. Pat. No. 6,510,962 describes a device that can be loaded withappropriate pills and programmed to automatically dispense the properamount(s) and proper type(s) of pill(s) at the proper time(s) each day.The device includes a system for alerting the pill taker that pills havebeen dispensed, a system for providing voice messages to coach the pilltaker to use the device and consume the pills, and a system for alertingan off-site caregiver when the pill taker has not responded as requiredor when there is a problem with the operation of the device.

U.S. Pat. No. 6,449,218 describes an electronic device for holdingmedicines, typically pills, to be taken at different times and to remindthe user to take particular pills at specific times. A first containerhas a plurality of pill holding compartments, with a hinged lid closingeach compartment. A second container, which is releasably fastenable tothe first compartment, contains a microprocessor, an alarm, a displayand buttons for controlling the microprocessor to display differentinformation. The display can be set to show the time, times for takingpills from different compartments, whether pills have been taken ontime, if a pill has been missed or skipped, when the last pill has beentaken, etc. When a time set for taking a pill arrives, an alarm,typically a light and/or sound alarm, alerts the user as to thecompartment holding the pill to be taken. A pill splitter is furtherprovided that can be releasably fastened to one of the compartments andprovides quick, accurate and safe splitting of pills so that halves maybe placed in the compartments to be taken as indicated by the alarmsystem.

SUMMARY

In one aspect, a method for dispensing one or more pills from a pill boxincludes applying power when the one or more pills are poured from thepill box; identifying an opened compartment and an opening time; andrecording the opened compartment and the opening time.

Implementations of the above method can include one or more of thefollowing. The system can check the opening time against one or moremedication constraints. The medical constraint includes takingmedication on a full stomach, a non-empty stomach or taking medicationon an empty stomach. The system can generate an alarm if medication istaken without meeting the appropriate food restriction. For example, ifthe medication is taken around normal lunch time when the medicationshould have been taken on an empty stomach, the system provides awarning and reports the event. The system can also check for multiplecompartment openings during one medication dispensing event andappropriate alarm(s) can be generated if there is a compliance issue.The system can wirelessly transmit the recorded opened compartment andopening time to a computer such as a patient computer, a cell phone, aremote server through the patient computer over the Internet, or aremote server using Bluetooth and cellular channel. One or moreauthorized persons can review the medication dispensing. The system canalso automatically request a medication refill from a pharmacy or from adoctor, for example.

In another aspect, a medication pill box includes a processor to detectone or more compartment openings for a pill box; a power source; and apill dispensing sensor coupled to the power source and the processor,the pill dispensing sensor applying power to the processor when one ormore pills are poured from the pill box.

Implementations of the above method can include one or more of thefollowing. The pill box has one or more switches each coupled to a pillbox compartment door to detect a compartment door opening. The switchcan be a first electrically conductive portion on the compartment dooradapted to contact a second electrically conductive portion on a pillbox wall adapted to contact the door. The processor can check a dooropening time against one or more medication constraints. The medicalconstraint can include taking medication on one of: a full stomach, anon-empty stomach and an empty stomach. The processor can also check formultiple compartment openings during one medication dispensing event. Awireless transmitter can send the recorded opened compartment andopening time to a computer. The computer allows one or more authorizedpersons to review the medication dispensing. The system can alsoautomatically request a medication refill when the medication is almostcompletely dispensed. The tilt sensor such as a pendulum, anaccelerometer, or a magnetic sensor can be used. The pill dispensingsensor can be a door open switch, a door closed switch, a motion sensor,a pendulum, an accelerometer, or a magnetic sensor. The system providesa built-in secure compartment for storing the pills. The system alsoassists users, especially those suffering from senility or deteriorationof mental function, in complying with their prescriptions. The systemavoids the situation where users may simply deactivate the pill alertsignal as they would do when turning off an alarm clock, and forget totake the dispensed pills. The system provides special instructions thatthe pill taker must follow in consuming the dispensed pills, such astaking the dispensed pills with plenty of liquids, or food, and the pilltaker may forget these instructions. The system automatically determineswhen to refill the dispenser with pills. The system can automaticallyrequest a refill from a doctor and forward the refill prescription to apharmacy for filling. Patient safety is enhanced while the cost ofemergency treatment due to non-compliance is reduced. Further, thesystem's wireless monitoring of drug compliance is cost-effective andconvenient to the patient.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an exemplary system that tracks medication taken by apatient.

FIG. 2 shows an exemplary mesh network for data transmission by thesystem of FIG. 1.

FIG. 3 shows an exemplary pill box.

FIGS. 4A-4B show exemplary closed and open states for a pill-dispensingdetector in the pill box of FIG. 3.

FIG. 5 shows an exemplary method for dispensing one or more pills fromthe pill box and collecting medication compliance information.

FIG. 6 shows an exemplary method for dispensing pills/compliancemonitoring and collecting patient data as well as providing educationalinformation to the patient regarding the treatment using the pill box.

DESCRIPTION

FIG. 1 shows an exemplary system that tracks medication taken by apatient. In this system, a power source 10 such as a battery providespower for a pill box 44 (as shown in FIG. 3). A pill pouring detector isused to connect the power terminal of the power source 10 to a controlelectronic 20 when pills are poured from the pill box 44 so that thepatient can take the medication.

In one embodiment, the pill pouring detector is a tilt-sensor. Thetilt-sensor can include a pendulum 12 that contacts an electrode 14 whenthe pills are poured from its respective compartment. A wire 11 connectsthe pendulum 12 to the power source 10 at terminal A, while a wire 13connects the electrode 14 to the control electronic 20 at terminal B.

The pendulum 12 can be connected to an optional spring (not shown) toenable the pendulum 12 to contact the electrode 14 quickly. In oneembodiment, one end of the spring is attached to the pill box and theother end attached to the top of the pendulum 12. The spring assists thependulum to touch the electrode 14, thereby forming a conductive circuitfor powering the electronic 20. The pendulum 12 can also be connected toan optional return spring (not shown) to enable the pendulum 12 toseparate quickly.

The electrode 14 can also have an optional magnet (not shown) to attractthe pendulum 12. In other embodiments, an accelerometer can be used tosense motion, or a magnet sensor can be used to detect the pill-pouringact by the patient. In yet other embodiments, a photo-detector or acamera can be positioned underneath the pill box to sense the presenceor absence of pill(s) after the door is opened, for example. Otherapproaches can be used to detect pill pouring as well.

The control electronic 20 can be an integrated processor and radiosystem-on-a-chip. In one embodiment, the control electronic 20 can be amesh network system such as ZigBee system, for example. Suitable controlelectronic 20 can include one chip solutions from Freescale and TexasInstruments/ChipCon, among others. The control electronic 20 hasintegrated mesh-network wireless transceivers, in this case ZigBeetransceivers whose network features are described in more details inFIG. 2. The processor can maintain clock data using interrupt handling,or alternatively a real-time clock chip can be used to provide time ofday information with precision.

In one implementation, the doors and corresponding door tabs that keepthe door secured when closed are made of a conductive material such assilver or conductive plastics. When closed, the door and the door tabare electrically shorted together and thus form a circuit. When opened,the door and the door tab are electrically isolated, and the closing oropening of each door can be determined by sampling the current orvoltage present on each door. The data input and output pins of theprocessor can be connected to door opening detection switches 16 usingsuitable pull-up resistors 18. Alternatively, pull-down resistors can beused to detect door openings/closings. The door opening/closing sensoris one type of pill dispensing sensor, and other sensors can include amotion sensor (such as PIR sensor), a pendulum, an accelerometer, or amagnetic sensor.

Optionally, a power switch 19 can be provided to allow the controlelectronic 20 sufficient time to complete its operation before releasingpower in case the pendulum 12 separates from the electrode 14 before thecontrol electronic 20 is ready. When power is initially applied by thependulum 12, the control electronic 20 turns on the switch 19 to assurethat power will be available as long as needed. When the controlelectronic 20 is done, it disables the power switch 19 to cut off power.The power switch 19 can be an electromechanical relay or a powertransistor or any other suitable switches. The use of the pendulum 12thus conserves battery energy and the use of the power switch 19 enablesan orderly shut-down by the control electronic 20.

The control electronics 20 communicate wirelessly with a computer 20which is connected to a wide area network 30 such as the Internet. Thecomputer 20 can be a home server which authorized persons can log-in tomonitor drug usage by the patient. Alternatively, the computer 20 cantransfer data over the WAN 30 to a remote server which centralizes datafrom the patient for one or more groups to review.

FIG. 2 shows an exemplary mesh network for medication compliance datatransmission by the system of FIG. 1. In one embodiment, the meshnetwork is an IEEE 802.15.4 (ZigBee) network. IEEE 802.15.4 defines twodevice types; the reduced function device (RFD) and the full functiondevice (FFD). In ZigBee these are referred to as the ZigBee PhysicalDevice types. In a ZigBee network a node can have three roles: ZigBeeCoordinator, ZigBee Router, and ZigBee End Device. These are the ZigBeeLogical Device types. The main responsibility of a ZigBee Coordinator isto establish a network and to define its main parameters (e.g. choosinga radio-frequency channel and defining a unique network identifier). Onecan extend the communication range of a network by using ZigBee Routers.These can act as relays between devices that are too far apart tocommunicate directly. ZigBee End Devices do not participate in routing.An FFD can talk to RFDs or other FFDs, while an RFD can talk only to anFFD. An RFD is intended for applications that are extremely simple, suchas a light switch or a passive infrared sensor; they do not have theneed to send large amounts of data and may only associate with a singleFFD at a time. Consequently, the RFD can be implemented using minimalresources and memory capacity and have lower cost than an FFD. An FFDcan be used to implement all three ZigBee Logical Device types, while anRFD can take the role as an End Device. In other embodiments, Bluetoothtransmitters, cellular transmitters, WiFi transmitters, or WiMaxtransmitters can be used.

FIG. 3 shows an exemplary pill box. In this embodiment, the pill box hasa seven-day planners with removable dividers that allow for 1 or 2compartments for storing medicine. The pill box enables the patient tokeep all of your medicines organized by day and time of day (AM/PM). Thetop of each lid has the first letter of each day of the week imprintedon it in very large black letters. In addition each letter can bestamped out in Braille. The pill box 50 has a door 40 with a conductivetab that acts as a switch 16. Upon door closure, the switch 16 is closedand upon door opening, the switch 16 is in an open state to indicate tothe control electronic 20 that the door is in an open state or a closedstate. The switch 16 can be made of a conductive elastomeric material ora silver ink or any other suitable conductor as long as the material canhandle repetitive door openings and closings.

FIG. 4A-4B show an exemplary detector in the pill box of FIG. 3 todetect the pouring of pills from a compartment of the pill box. FIG. 4Ashows a compartment 50 having a door 40 at a rest (not tilted) position.The electrode 14 is connected to the wire 13 to terminal B, while thependulum 12 is connected to the wire 11 to terminal A. The pendulum 12is swivably mounted on a hinge 15. FIG. 4B shows the pill box beingtilted. As a result of the tilt, the pendulum 12 contacts the electrode14 to complete the circuit and provide power to the control electronic20. This approach turns on power only when necessary, and thus savesbattery life and provides for a carefree operation where the patientneeds not worry about battery replacement as the pill box can last foryears. The pill box can be designed so that the battery can be replaced.Alternatively, the pill box can be disposable so that when the batteryis depleted, a new pill box can be used to provide recurring revenue forthe manufacturer.

FIG. 5 shows an exemplary method for dispensing one or more pills fromthe pill box. The method applies power to the control electronic 20 whenthe one or more pills are poured from the pill box (100). The controlelectronic 20 then identifies an opened compartment and an opening time(102). As discussed above, the switches 16 are used to determine theopening of one or more doors and a real-time clock chip can be used todetermine the time of door opening. The control electronic 20 recordsthe opened compartment and the opening time (104). The controlelectronic 20 also checks the opening time against one or moremedication constraints and if so, generates an alarm if the medicationconstraint is violated (106). The medical constraints are typically setby the pharmaceutical company, by the FDA, or by the doctor. Theconstraints can be, for example, taking medication on a non-emptystomach or alternatively can be taking medication on an empty stomach.The control electronic 20 also checks for multiple compartment openingsduring one medication dispensing event and if so, generates an alarm(108). The control electronic 20 wirelessly transmits the recordedopened compartment and opening time to a computer (110) that can be thepatient's home computer with a mesh network wireless communicationdevice mounted therein to receive the data. The computer can store thedata, or can upload the data to a central server over the Internet 30.The computer or the server can allow one or more authorized persons toreview the medication dispensing (112) and can also request a medicationrefill (114).

FIG. 6 shows an exemplary method for dispensing pills/compliancemonitoring and collecting patient data as well as providing educationalinformation to the patient regarding the treatment using the pill box.The process optionally asks if the patient would like information aboutmedication and if so display a summary of the medication, requirementsprior to taking medication, and potential side effects or warnings(200). The information can be supplied by a pharmacist and downloaded orprogrammed into the pill box for display. Alternatively, the pill boxcan access a search engine and provide the information to the patient.Next, the system identifies an opened compartment and an opening time(202) and records the opened compartment and the opening time (204). Thesystem checks the opening time against one or more medicationconstraints and if so, generates an alarm if the medication constraintis violated (206). The system can check for multiple compartmentopenings during one medication dispensing event and if so, generate analarm (208). Optionally, the pill box can query other devices to collectinformation on patient (210). For example, the pill box can prompt thepatient to obtain EKG and/or blood pressure from a suitable device thatcommunicates over the mesh network. The data is collected and saved bythe pill box electronic. The pillbox can also optionally display one ormore predesigned questions about the user's health and collect answer(s)from the question(s) (212). Such questionnaires can include questions onthe patient's general feeling and health assessment, questions on thepatient's sugar level and blood pressure, questions about the type offood, the type of exercise, or any other questions that a healthcareplan, Medicare/Medicaid, employer health plan, or other suitable payorsor physicians, nursing home directors, or family members may want thesystem to collect. The system then wirelessly transmits the recordedopened compartment(s) indicative of medication compliance and othercollected patient data to a computer (214). The data is sent to a serverand one or more authorized persons can, upon authentication, review themedication compliance information and collected patient data (216). Thesystem can also requests a medication refill if needed (218).

In yet another embodiment, a pillbox is positioned on a scale or weightmeasurement device. The weight of each pill to be taken by a person isidentified in advance, and the total weight of all pills to be taken inone batch, for example morning pills, is determined. When the pillbox isremoved and placed back on the cradle, the new weight of the pillbox isdetermined. If the new weight is approximately equal to the old weightminus the total weight of pills to be taken in one patch, the systeminfers that the pills have been removed and (presumably) taken by thepatient. If the new weight is not as expected, an error is indicated sothat the patient, a caretaker, or the physician is notified of apotential drug non-compliance.

While the system above monitors the dispensing one or more pills from apill box by applying power when the one or more pills are poured fromthe pill box; identifying an opened compartment and an opening time; andrecording the opened compartment and the opening time, the system canalso monitors the pill dispensing by applying power when the compartmentdoor is opened and then detecting which door has been opened. Hence, thetilt detector (such as the pendulum) is not needed in all embodiments.

1. A method for dispensing one or more pills from a pill box,comprising: a. applying power when one or more pills are poured from thepill box; b. identifying an opened compartment and an opening time; c.moving a pendulum to an electrode to detect a pill box tilt condition;and d. recording the opened compartment and the opening time.
 2. Themethod of claim 1, comprising checking the opening time against one ormore medication constraints.
 3. The method of claim 2, wherein themedical constraint comprises taking medication on one of: a fullstomach, a non-empty stomach, an empty stomach.
 4. The method of claim2, comprising generating an alarm.
 5. The method of claim 1, comprisingchecking for multiple compartment openings during one medicationdispensing event.
 6. The method of claim 5, comprising generating analarm.
 7. The method of claim 1, comprising wirelessly transmitting therecorded opened compartment and opening time to a computer.
 8. Themethod of claim 1, comprising allowing one or more authorized persons toreview the medication dispensing.
 9. The method of claim 1, comprisingrequesting a medication refill.
 10. A medication pill box, comprising:a. a processor to detect one or more compartment openings for a pillbox; b. a power source; and c. a pill dispensing sensor coupled to thepower source and the processor, the pill dispensing sensor applyingpower to the processor when one or more pills are poured from the pillbox when a pendulum moves to an electrode to detect a pill box tiltcondition, wherein the processor identifies and records an openedcompartment and an opening time.
 11. The pill box of claim 10,comprising one or more switches each coupled to a pill box compartmentdoor to detect a compartment door opening.
 12. The pill box of claim 11,wherein each switch comprises a first electrically conductive portion onthe compartment door adapted to contact a second electrically conductiveportion on a pill box wall adapted to contact the door.
 13. The pill boxof claim 10, comprising processor executable code to check a dooropening time against one or more medication constraints.
 14. The pillbox of claim 13, wherein the medical constraint comprises takingmedication on one of: a full stomach, a non-empty stomach and an emptystomach.
 15. The pill box of claim 10, comprising processor executablecode to check for multiple compartment openings during one medicationdispensing event.
 16. The pill box of claim 10, comprising a transmitterto send the recorded opened compartment and opening time to a computer.17. The pill box of claim 16, wherein the computer allows one or moreauthorized persons to review the medication dispensing and wherein thecomputer requests a medication refill.
 18. The pill box of claim 16,wherein the transmitter communicates with a mesh network.
 19. The pillbox of claim 10, wherein the pill dispensing sensor comprises one of: adoor open switch, a door closed switch, a motion sensor, a pendulum, anaccelerometer, a magnetic sensor.